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FDA 510(k)

SIEMENS-ELEMA PULSE GENERATOR 668 B

K-Number: K812610 · 1981-12-10

ApplicantSiemens Corp.
Decision Date1981-12-10
Product CodeDXY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIEMENS-ELEMA PULSE GENERATOR 668 B is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Corp.. It received FDA 510(k) clearance on 1981-12-10 under 510(k) number K812610. The device is classified under product code DXY. It was reviewed by the CV advisory panel. Product code DXY falls under the category of Clinical Chemistry, which covers reagents and instruments for chemical analysis of clinical samples. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMENS-ELEMA PULSE GENERATOR 668 B?

SIEMENS-ELEMA PULSE GENERATOR 668 B is a medical device that received FDA 510(k) clearance on 1981-12-10. The listed applicant is Siemens Corp.. The 510(k) number is K812610.

When did SIEMENS-ELEMA PULSE GENERATOR 668 B receive FDA 510(k) clearance?

SIEMENS-ELEMA PULSE GENERATOR 668 B received FDA 510(k) clearance on 1981-12-10, under 510(k) number K812610.

Who is the listed applicant for SIEMENS-ELEMA PULSE GENERATOR 668 B?

The FDA 510(k) record lists Siemens Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIEMENS-ELEMA PULSE GENERATOR 668 B?

The FDA product code for SIEMENS-ELEMA PULSE GENERATOR 668 B is DXY. This falls under the Clinical Chemistry category.

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Related Devices (Code: DXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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